Associate Director, Analytical Development (Bioassay)

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

About the Role:

We're looking for an Associate Director, Analytical Development (Bioassay) on the Biologics Analytical Development & QC team to help us expand what's possible for patients with serious diseases. Reporting to the Senior Director, Large Molecule Analytical Development & QC, you'll lead method development, qualification/validation and troubleshooting of potency assays/bioassays and impurity assays for biologic products while providing scientific and technical leadership for phase appropriate biological characterization of monoclonal antibodies, fusion proteins, enzymes and other biologics.

What You'll Do:

In this role, you'll have the opportunity to serve as CMC analytical leader and liaison for one or more biologics programs, effectively communicating scientific strategy, risks, and results to senior leadership and cross-functional teams. You'll also:

• Lead and oversee the design, development, phase appropriate validation, and troubleshooting of potency assays (plate based and cell-based bioassays), and impurity assays leveraging technical platforms such as ELISA, SPR, BLI, MSD at the internal and external (CDMO/CRO) laboratories
• Partner with R&D, CMC and other senior stakeholders to lead and manage laboratory activities supporting the early to late-stage biologics portfolio to meet the highest scientific and regulatory standards
• Build, mentor, and develop a high-performing team of scientists, fostering a culture of scientific excellence and continuous improvement
• Manage relationships with CROs, CDMOs, and other external partners; oversee technical transfers and ensure quality and timelines are met
• Lead the authoring and review of appropriate analytical sections of regulatory submissions (IND, IMPD, MAA and BLA); represent the organization in regulatory interactions and health authority responses
• Ensure all activities are aligned with CMC strategy, GMP requirements, and global regulatory expectations (FDA, EMA, PMDA, HC, ICH)
• Maintain oversight of laboratory records, SOPs, protocols, and technical reports to ensure compliance and data integrity

Who You Are:

You have a minimum Ph.D. in Biochemistry, Molecular Biology, or a related life sciences discipline along with 3+ years of relevant industry experience in bioassay development and biologics characterization, or M.S. with 7+ years of experience.

You are or you also have:

• Demonstrated leadership experience in bioassay design and development, biologics characterization, and analytical method development within a biopharmaceutical setting
• Proven track record of managing and mentoring scientific teams and influencing cross-functional stakeholders and external eminence through industry consortiums and conferences
• Deep expertise in GMP requirements and regulatory expectations for biologics related to potency assay and biological characterization (IND, IMPD and BLA submissions)
• Strong strategic thinking, problem-solving, and decision-making capabilities
• Excellent written and verbal communication skills, with experience presenting to senior leadership and regulatory agencies
• Experience managing external partners (CROs, CMOs) and overseeing technical transfer activities

Where You’ll Work

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

Minimal travel expected

#LI-MC1

#LI-ONSITE

Pay Range:

$155,000.00-201,500.00 Annual

Life at Insmed
 

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)

• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration

• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance

• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities

• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. 

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@insmed.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.